Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
77377 
experiments assigned containment conditions 
in the Guidelines. Investigators would be 
required to notify their Institutional Biosafety 
Committees prior to the initiation of 
experiments and those committees would be 
responsible for reviewing the registration 
documents for consistency with the 
provisions of the Guidelines and advising the 
investigators of necessary changes. No 
Memoranda of Understanding would be 
required. IBCs and investigators would still 
be expected to petition the ORDA regarding 
experiments not explicitly covered by the 
Guidelines, experiments requiring case-by- 
case review and experiments involving 
exceptions to the provisions (or prohibitions). 
The NIH and the RAC would function as 
policy making elements with responsibility to 
change the Guidelines as required, to 
evaluate containment requirements for 
experiments not explicitly covered by the 
Guidelines, and for consideration of 
exceptions. 
Seven years have passed since the 
scientific community first raised questions 
regarding recombinant DNA experiments. 
The ignorance of those early years has been 
supplanted with a wealth of experience and 
information. Just as the early stringent 
Guidelines were promptly adopted in 
response to the ignorance, we must now 
respond just as promptly to the current more 
realistic appraisals. 
The proposed revisions were 
published in the Federal Register of 
August 21, 1980, for comment, as Item 8 
of the notice. Specific changes were 
proposed in many different places in the 
Guidelines, specified under subheadings 
“A” through “X” within Item 8. 
Seventeen letters were received 
commenting on the proposal. Sixteen 
commentators supported its adoption. 
One commentator stated: 
Maxine Singer's initiative (Federal 
Register, August 21, 1980) to have the NIH 
Guidelines fall primarily under local control 
is both wise and timely. Decisions about 
scientific research are best left to the 
investigtors both for efficiency and as a 
matter of fundamental principle. Only in 
exigency, should this ideal be violated. 
Perhaps we've passed through such an 
occasion with R-DNA research. However, it 
is now the time to return to the more normal 
situation. Since work with recombinant DNA 
has proven to be very safe and very 
important, dual review at the national and 
local levels serves no good purpose. 
As one involved from the beginning in the 
R-DNA issue, I’ve always felt that the 
‘Guidelines' should be guidelines; they turned 
into regulations. With the proposed change, 
they will revert and also the unfortunate 
quasi-regulatory role that the NIH has had to 
play will begin to disappear. 
Another commentator said: 
I think the IBC mechanism has proven its 
effectiveness in interpreting and enforcing the 
letter and intent of the Guidelines governing 
recombinant DNA research. I do not see how 
the practices of submission, obtaining and 
recording, etc., of MUA's particularly the 
requirements for annual submissions of 
MUA's for each continuing NIH grant or for 
applications for new grants, contributes to 
the safety of research. An updated statement 
of work in progress from each investigator to 
the IBCs would be significantly simpler to 
administer and would ensure as much real 
safety as the present system. 
Another observed: 
I agree with her that the function of review, 
registration, and monitoring of research 
workers falling into categories explicitly 
mentioned in the Guidelines can be 
effectively administered by the local 
Institutional Biosafety Committees. This 
would reduce the workload for ORDA 
allowing it to spend more time determining 
policy and revising the Guidelines according 
to requests or to new data. It would 
simultaneously ease the bureaucratic 
workload for the researcher without 
jeopardizing the effectiveness of the 
Guidelines. Not only are the procedures 
described in the Guidelines now standard 
practice among most laboratories, as pointed 
out by Dr. Singer, but I feel that the local 
Institutional Biosafety Committees are in 
much better position to evaluate compliance 
with the Guidelines. Because of their past 
experience with the Guidelines, I feel that 
these committees are ideally suited to take 
over this important administrative role. 
One commentator made the following 
observation about Institutional 
Biosafety Committees: 
Institutional Biosafety Committees clearly 
seem able to operate as independent review 
groups, and the laboratory practices set forth 
in the Guidelines have now become part of 
the standard operating procedures of 
laboratories working in the field. In other 
fields of biological research, safety 
procedures are implemented entirely at the 
local level, even when known biohazards are 
involved. It is no longer necessary to have a 
unique multi-level system in an area where 
seven years of extensive experience has 
shown the absence of a unique hazard. 
Another commentator said the 
following about central review: 
Elimination of central review at NIH for 
experiments classified in the Guidelines will 
save a great deal of time for both the 
investigator and the reviewers at NIH. I 
believe the experience of the past six years 
justifies a change toward an administrative 
arrangement long successfully practiced in 
the handling of proven microbial pathogens, 
namely national guidelines enforced by local 
biosafety committees. 
One commentator made the following 
observation about the current system of 
NIH review: 
The present complex system of review on 
both local and Federal levels is no longer 
necessary. It is wasteful of time, effort, and 
money. It is, in fact, counterproductive 
because bureaucratic requirements seen by 
investigators to be clearly unnecessary lead 
to disrespect for regulations that should be 
respected. Institutional Biosafety Committees 
should, in my opinion, be fully capable of 
monitoring laboratory practices and 
containment levels specified by the 
Guidelines. 
Another letter included the following 
remark: 
I strongly endorse the proposed changes 
because I believe that the risks of this 
research are now clearly minimal and 
because the bureaucracy and consequent 
wasted time are truly detrimental to progress 
in an area that promises to be of great benefit 
to mankind. 
The Chairman of one IBC reporting 
the unanimous endorsement of his 
committee stated: 
We feel strongly that safety is solely a 
function of the effectiveness of the local 
institutional practices, on the part of the Pi's 
and the IBC, in complying with and enforcing 
the Guidelines. The submission of MUAs 
adds nothing but expensive and time- 
consuming paperwork. 
The one letter against the proposal 
stated the following: 
At present, we do not believe that there are 
good reasons for changing the registration 
requirements. Although present procedures 
demand some extra paperwork, they permit 
centralized keeping of files which could be of 
significant use in reviewing the extent of 
work on recombinant DNA and its possible 
hazards. Somebody should know what is 
going on. 
The RAC discussed the proposal at 
length at its September 25-26, 1980 
meeting. Dr. Singer, who attended this 
portion of the meeting, summarized the 
proposal and presented her arguments 
for adopting it. It was noted that the 
proposal has two major aspects, which 
could be acted upon separately. The 
first aspect is that it would eliminate 
NIH review of protocols for which 
containment levels are specified by the 
Guidelines. The second aspect is that 
the proposal would eliminate the 
requirement for pre-review by the local 
IBC prior to initiation of all experiments 
for which containment levels are 
specified by the Guidelines (Prior review 
is already not required for most 
experiments). Some members of the 
RAC felt that adoption of the proposal 
should be delayed until a broad-based 
survey of the functioning of IBCs is 
completed. Some members of the RAC 
felt that pre-review of all experiments 
by the IBC should not be eliminated at 
the present time. The RAC then voted 
separately on a four-part motion 
proposed by Dr. Gottesman. 
The RAC voted 15 in favor, 3 opposed, 
with no abstentions, to eliminate the 
requirement for NIH review of IBC 
decisions on any experiments for which 
containment levels are specified in the 
Guidelines. 
The RAC voted 12 in favor, 5 opposed, 
with 1 abstention, to defer consideration 
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